96
Participants
Start Date
September 9, 2025
Primary Completion Date
December 19, 2025
Study Completion Date
December 19, 2025
mRNA-1645-eODGT8
eOD-GT8 60mer is a self-assembling nanoparticle composed of 60 subunits of the engineered HIV-1 gp120 outer domain germline targeting version 8 (eOD-GT8) fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 15-amino acid Glycine-Serine linker. eOD-GT8 60mer will be delivered using an mRNA lipid nanoparticle (LNP) platform. To be administered by intramuscular (IM) injection at doses of 10 or 30 mcg.
mRNA-1645-CoreG28v2
core-g28v2 60mer is a nanoparticle composed of 60 protein subunits of an engineered core-gp120 fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 21-amino acid Glycine-Serine linker. Core-g28v2 60mer will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg.
mRNA-1645-N332GT5
"N332-GT5 gp151 is an HIV envelope glycoprotein gp151 trimer based on BG505 SOSIP MD39 (clade A) trimer with germline-targeting mutations added that confer the ability to bind germline precursors of BG18 class B cells. N332-GT5 gp151 will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg."
Placebo
Saline
Soweto HVTN CRS, Soweto
Klerksdorp CRS, Klerksdorp
CAPRISA eThekwini CRS, Durban
Chatsworth CRS, Chatsworth
Isipingo CRS, Isipingo Rail
Emavundleni CRS, Cape Town
Groote Schuur HIV CRS, Cape Town
Setshaba Research Centre CRS, Soshanguve
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
ModernaTX, Inc.
INDUSTRY
National Institutes of Health (NIH)
NIH
Bill and Melinda Gates Foundation
OTHER
United States Agency for International Development (USAID)
FED
The Scripps Research Institute
OTHER
International AIDS Vaccine Initiative
NETWORK
HIV Vaccine Trials Network
NETWORK